510(k) K944265 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
NEEDLE ELCTRODE
| Applicant | Unimed Surgical Products, Inc., Largo FL, US |
| Decision | Substantially Equivalent, May 5, 1995 |
| Received | Sep 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944265
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufa Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.co Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***S Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STE Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STE Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.co Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STER Terminated |
GEI | None listed |
| Aug 28, 2012 | Unimed Surgical Products, Inc. Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STER Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.